Surgical sponges with flexible rfid tags

ABSTRACT

A surgical sponge is provided, having a radiofrequency (RF) tag positioned interior thereto. The RF tag has a base layer with at least one tab projecting from an outer perimeter of thereof. The RF tag has a first protective layer with at least one tab projecting from the outer perimeter of the RF tag and generally aligned with the at least one tab of the base layer and an RF identifier laminated between the base layer and the first protective layer. The RF identifier has an antenna, and an electrically responsive member. The antenna can be a metal foil loop antenna etched on to the base layer. The RF identifier can include additional metal foil provided on the base layer when the metal foil loop antenna is etched on to the base layer, the additional metal foil configured to enhance x-ray opacity of the sponge.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. Nonprovisionalapplication Ser. No. 16/853,112, filed Apr. 20, 2020, which was acontinuation of U.S. Nonprovisional application Ser. No. 16/561,005,filed Sep. 4, 2019, which was a continuation of U.S. Nonprovisionalapplication Ser. No. 15/695,575 filed Sep. 5, 2017, which applicationsare incorporated herein by reference in their entirety.

BACKGROUND

Surgical sponges are commonly used during surgical procedures to absorbbody fluids, mostly blood, of the patient both inside the incision andaround the site of surgery. Sponges of this nature are usually made ofan open ended absorbent fabric such as woven cotton. When used, surgicalsponges become saturated with blood, alter in size and shape andtherefore become hard to distinguish from body tissue and each other.For this reason, surgical sponges can be hard to identify and accountfor both during and after a surgical procedure. Surgical sponges can beinadvertently left inside the patient at the end of surgery. Thisproblem can become magnified in larger surgical procedures where thereare a large number of sponges used. Surgical items may have to becounted before and after surgical procedure. Surgical sponges can be adifficult item to account for before, during and especially after asurgical procedure. Typically medical personnel count these items byhand, based on human visual detection in the body and visual detectionand counting to differentiate one sponge from another and account forthe sponges when outside the body. If a sponge count taken during orafter a procedure does not match the sponge count taken before theprocedure, an x-ray can be taken of the surgical site to detect whetheror not the missing sponge is still in the patient.

Thus, this method is prone to human error and is therefore unreliableand inefficient. The large amount of time involved in differentiatingthe sponges from one another and accounting for them leads to largecosts. Additionally, the unreliable nature of the method can lead tomiscounted sponges resulting in surgical sponges being inadvertentlyretained inside the patient. Such issues may adversely affect not onlythe health of the patient, but may also prove costly to the hospital andinsurance companies involved.

SUMMARY

In some embodiments of the present disclosure, substantially flatantennae are used to allow lamination between two or more layers ofpolymeric film. The substantially flat antennae may be loop-shaped orany other suitable shape. These antennae may be made from an etchedmetal foil applied to a base film layer of stretch-resistant polymericfilm. RFID tags of this construction are commonly referred to as “inlaytags.” Alternately, in some embodiments the antennae may be made ofmultiple loops of wire.

In some embodiments, an electrically responsive member is electricallyconnected to the antenna. An electrically responsive member may includean integrated circuit (IC) chip, a capacitor, a resistor, otherelectrical components or combinations of these components which areelectrically connected to the antenna creating an identifier. If theidentifier includes an IC chip, it may be called a Radio FrequencyIdentification (RFID) identifier. If the identifier includes a capacitorwith or without a resistor, it may be called a Radio Frequency (RF) orLow Frequency identifier.

In some embodiments, a planar and/or flexible identifier can belaminated between two or more layers of polymeric film creating a flat,flexible tag. The planar and/or flexible tag may also be mechanicallydurable, waterproof and able to withstand sterilization.

In some embodiments, the inlay identifier includes a base layer ofstretch-resistant polymeric film that reduces the chances of fracturingof metal foil antennae traces during stretching and bending. In someembodiments, a single protective layer of polymeric film may belaminated to the base layer to cover and protect the exposed inlayidentifier.

In some embodiments the inlay identifier or wire loop identifier may belaminated between two or more protective film layers. The protectivefilm layers may be made of flexible polymeric film that may berelatively resistant to tearing.

White sponge material that has absorbed blood may turn red and mayresemble tissue. Accordingly, in some embodiments, the protective layerof polymeric film may be colored. In some such embodiments, the colormay other than a clear color to make the protective layer more visibleto the surgeon. Bright colors that contrast blood and tissue may be usedin some advantageous aspects of the present disclosure. In someembodiments, materials or colors that “fluoresce” in natural light maybe used. In some embodiments, materials or colors that “fluoresce” whenilluminated by UV light or colored lights may be included in theprotective film layers or coated on to the film. In some embodiments,reflective materials may be included in or on the protective film layer.

In some embodiments, the one or more protective film layers maybe madeof a substantially hydrophobic polymeric material to reduce the chancesof blood from coating the film. Alternately, a hydrophobic material maybe coated on to the protective layers.

In some embodiments, the base film layer with its attached antenna andelectrically responsive member bonded to one or more protective filmlayers may be called an RFID tag or RF tag. The outline shape of the tagmay generally follow the shape and size of the sponge. Alternately,outline shape of the tag may be slightly larger than the general outlineof the identifier within the tag. The antenna of the identifier may becircular, oval, square, rectangular, elongate rectangular or evencomplex shapes such as a clover-shape. Therefore the tags can be anycorresponding shape as well. The size and shape of the antenna candetermine the limits of the size of the tags.

In some embodiments, when the antenna is circular, square orrectangular, there is a space within the inner perimeter of the antennathat is void of metal foil traces. In some embodiments, the base filmlayer and the one or more protective film layers within the area definedby the inner perimeter of the antenna trace may be removed, creating ahole through the central area of the tag. This hole may increase theflexibility and the overall stretch-ability and the ability to deformlike gauze fabric so that the tag feels like it is the sponge ratherthan being a sheet of plastic interposed between the layers of the gauzesponge.

In some embodiments, some of the material of the base and protectivefilm layers may be left extending outward from the outer perimeter ofthe tag. The material may be in the shape of one or more tabs extendingradially outward.

In some embodiments, some of the material of the base and protectivefilm layers may be left within the perimeter of the hole in the tag. Thematerial may be in the shape of one or more tabs extending radiallyinward from the inner perimeter of the hole on the tag.

In some embodiments, the tabs extending inward into the hole or outwardfrom the outer perimeter of the tag are used for anchoring the tag tothe sponge without damaging the fragile antenna.

In some embodiments, the tag can be attached to the sponge by sewingthrough both the sponge material and the base and protective film layersof the tag. Sewing through the one or more tabs can reduce the chance ofcutting a foil trace of the antenna or a wire of the antenna with thesewing needle.

In some embodiments, the one or more tabs become a safe area for heatbonding the tag to the sponge. Heat bonding may be accomplished byapplying a hot object to one or more layers of the sponge fabric whilepushing them firmly down onto the one or more layers of protective filmlayer. The heated object warms and partially melts the polymeric filmembedding the fibers of the sponge into the melted film.

In some embodiments, the tabs that allow heat bonding or sewing withoutdamaging the metal foil or conductive ink antenna traces can be used.Such tabs may permit an automated manufacturing process to be used inmaking the surgical sponges. This disclosure provides a method of makingsurgical sponges with an attached, flexible RFID or RF inlay tag. Theattachment location between the sponge and the tag may be at the one ormore tabs. Because the tabs are geographically separated from theelectrically functional parts of the identifier, less precision issufficient when applying pressure and heat or piercing with sewingneedles to avoid damaging the identifier. In some embodiments thisautomated manufacturing process may be used to manufacture surgicalsponges with markers made of one or more layers of plastic film but notincluding RFID or RF identifiers.

In some embodiments, the metal foil inlay identifier or the metal wireof a loop antenna creates a densely radio-opaque area easily visualizedby x-ray. In some embodiments, excess metal foil may be left on the basefilm layer during the etching process, substantially increasing thex-ray opacity of the metal foil at no extra cost.

In some embodiments, enhanced surgical sponge visualization and/orenhanced x-ray opacity may be desirable without RFID. Inexpensive andeasily identifiable markers may be made similarly to the RFID tagspreviously discussed in this disclosure except that the inlay identifieris omitted. The markers may be made of one or more layers of coloredpolymeric film with or without a metal foil layer for x-ray opacity. Themarker may then be attached by heat bonding, sewing or adhesives betweenthe layers of the surgical sponge as previously described. The markermay be any size or shape

In some embodiments, the sponges are spread out so that their antennaemay overlap or crossover but do not stack. Spreading the sponges outalso decreases the chances of packaging the wrong number of sponges inthe pack at the factory or miscounting during surgery. If each locationon the card is occupied by a single sponge, the correct number can beidentified with a cursory visual inspection by either a human or amachine.

In some embodiments, the sponge dispensing card may include a pressuresensitive adhesive area designed to anchor the card to the surgicalinstrument table. This allows for easier dispensing of the sponges fromthe card.

In addition, certain aspects of the present disclosure include thefollowing numbered embodiments:

-   -   1. A surgical sponge with radio-frequency identification (RFID)        counting and detection comprising:        -   a surgical sponge;        -   a flexible RFID identifier that includes an antenna and an            electrically responsive member which are laminated between a            base film layer and a first protective film layer creating a            flexible RFID tag;        -   the base film layer is made of a flexible stretch-resistant            polymeric film;        -   the first protective film layer is made of a flexible            tear-resistant polymeric film; wherein, the flexible RFID            tag is secured between the layers of the sponge material.    -   2. The surgical sponge of embodiment 1, wherein the antenna is        an etched metal foil loop antenna.    -   3. The surgical sponge of embodiment 1 or 2, wherein the antenna        is a wound wire loop antenna.    -   4. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the antenna is a loop antenna that is        substantially square configuration in order to maximize the        antenna size relative to the substantially square surgical        sponges.    -   5. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the electrically responsive member includes        a programmable integrated circuit (IC) chip.    -   6. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the electrically responsive member includes        a capacitor.    -   7. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the electrically responsive member includes        a capacitor and resistor.    -   8. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the base film layer of stretch-resistant        polymeric film is attached to the loop antenna for protecting a        foil antenna from tearing and an IC chip from dismounting.    -   9. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the stretch-resistant polymeric films that        may be suitable for the first material layer include but are not        limited to PET, PP, polyester and nylon.    -   10. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the first protective film layer comprises a        tear-resistant polymeric film to prevent tearing of the        laminated material layers forming the tag, especially along the        series of holes created by sewing or areas of material        weaknesses created by heat bonding.    -   11. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the tear-resistant polymeric films that may        be suitable for the second material layer include but are not        limited to urethane, nylon, PVC.    -   12. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the laminated RFID tag may include one or        more additional flexible protective film layers.    -   13. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the flexible film layers are bonded together        with an adhesive capable of withstanding temperatures in excess        of 250° F. for steam autoclave durability.    -   14. The surgical sponge of embodiment 1 or any previous        embodiment, wherein the thickness of the first protective film        layer forces the laminate to bend in a radius rather than a        kink, protecting the foil antenna from breaking during bending.    -   15. A surgical sponge with radio-frequency identification (RFID)        counting and detection comprising:        -   a surgical sponge;        -   a flexible inlay RFID identifier that includes a loop            antenna and an electrically responsive member which are            laminated between a base layer and a first polymeric            protective film layer creating an RFID tag;        -   the flexible RFID tag is positioned between the base layer            and a first polymeric protective film layer of the sponge            and is attached to the surgical sponge; wherein        -   the base layer and first protective layers are removed from            a portion of the area of the tag defined by the inner            perimeter of the loop antenna, creating a hole through the            flexible RFID tag for improved flexibility.    -   16. The surgical sponge of embodiment 15 or any previous        embodiment, wherein the antenna is at least one of: an etched        metal foil loop antenna or a wound wire loop antenna.    -   17. The surgical sponge of embodiment 16 or any previous        embodiment, wherein the loop antenna is a substantially square        configuration in order to maximize the antenna size relative to        the substantially square surgical sponges    -   18. The surgical sponge of embodiment 15 or any previous        embodiment, wherein the electrically responsive member includes        at least one of: a programmable integrated circuit (IC) chip or        capacitor or capacitor and resistor.    -   19. The surgical sponge of embodiment 15 or any previous        embodiment, wherein the tag includes two or more polymeric        protective film layers.    -   20. The surgical sponge of embodiment 15 or any previous        embodiment, wherein at least one of the polymeric protective        film layers is made of a flexible tear-resistant film for        enhanced durability when sewn.    -   21. The surgical sponge of embodiment 15 or any previous        embodiment, wherein the tag is attached to the sponge by sewing        through the tag and sponge material layers.    -   22. The surgical sponge of embodiment 15 or any previous        embodiment, wherein the tag is attached to the sponge by heat        bonding the fibers of the sponge to one or more of the polymeric        material layers of the tag.    -   23. The surgical sponge of embodiment 15 or any previous        embodiment, wherein one or more tabs of the laminated polymeric        material layers project inward from the inner perimeter of the        hole, into the hole area of the tag enabling easier sewing or        heat bonding of the tag to the sponge.    -   24. A surgical sponge with radio-frequency identification (RFID)        counting and detection comprising:        -   a surgical sponge;        -   a flexible RFID identifier that includes an antenna and an            electrically responsive member which are laminated between a            base layer and a first polymeric protective film layer            creating an RFID tag;        -   the flexible RFID tag is positioned between the layers of            the sponge material and is attached to the surgical sponge;        -   wherein one or more tabs of the laminated polymeric base and            protective film layers project outward from the outer            perimeter of the tag.    -   25. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the antenna is at least one of: an etched        metal foil loop antenna or a wound wire loop antenna.    -   26. The surgical sponge of embodiment 25 or any previous        embodiment, wherein the antenna is a loop antenna that is        substantially square configuration in order to maximize the        antenna size relative to the substantially square surgical        sponges.    -   27. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the electrically responsive member includes        at least one of: programmable integrated circuit (IC) chip or a        capacitor or a capacitor and resistor.    -   28. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the tag includes two or more polymeric        protective film layers.    -   29. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the at least one of the polymeric material        layers is made of a flexible tear-resistant film for enhanced        durability when sewn.    -   30. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the tag is attached to the sponge by sewing        through the tag and sponge material layers.    -   31. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the tag is attached to the sponge by heat        bonding the fibers of the sponge to one or more of the polymeric        material layers of the tag.    -   32. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the one or more tabs projecting outward from        the outer perimeter of the tag, enabling easier sewing or heat        bonding of the tag to the sponge.    -   33. The surgical sponge of embodiment 24 or any previous        embodiment, wherein the one or more tabs projecting outward from        the outer perimeter of the tag project beyond an edge of the        sponge when the tag is attached to the sponge.    -   34. A surgical sponge with radio-frequency identification (RFID)        counting and detection comprising:        -   a surgical sponge;        -   a flexible inlay RFID identifier that includes an etched            metal foil loop antenna and an electrically responsive            member which are laminated between a polymeric base film            layer and a first protective film material layer creating an            RFID tag;        -   the flexible RFID tag is positioned between the layers of            the sponge material and is attached to the surgical sponge;            wherein        -   the etching of the metal foil loop antenna leaves excess            metal foil still attached to the polymeric base film layer            to enhance x-ray opacity of the sponge.    -   35. The surgical sponge of embodiment 34 or any previous        embodiment, wherein the loop antenna is a substantially square        configuration in order to maximize the antenna size relative to        the substantially square surgical sponges    -   36. The surgical sponge of embodiment 34 or any previous        embodiment, the electrically responsive member includes at least        one of: a programmable integrated circuit (IC) chip, or a        capacitor or capacitor and resistor.    -   37. The surgical sponge of embodiment 34 or any previous        embodiment, wherein the tag includes two or more polymeric        protective film layers.    -   38. The surgical sponge of embodiment 34 or any previous        embodiment, one or more tabs of the one or more laminated        polymeric base and protective film layers project outward from        the outer perimeter of the tag, enabling easier attachment of        the tag to the sponge.    -   39. The surgical sponge of embodiment 34 or any previous        embodiment, wherein the one or more tabs of the laminated        polymeric base and protective film layers projecting outward        from the outer perimeter of the tag, also include a layer of        metal foil for enhanced x-ray opacity of the sponge.    -   40. The surgical sponge of embodiment 34 or any previous        embodiment, wherein the one or more tabs projecting outward from        the outer perimeter of the tag project beyond the edge of the        sponge when the tag is attached to the sponge.    -   41. The surgical sponge of embodiment 34 or any previous        embodiment, the polymeric base and protective film layers are        removed from a portion of the area of the tag defined by the        inner perimeter of the loop antenna, creating a hole through the        flexible RFID tag for improved flexibility.    -   42. The surgical sponge of embodiment 34 or any previous        embodiment, one or more attachment tabs of the laminated        polymeric base and protective film layers project inward from        the inner perimeter of the hole, into the hole area of the tag        and also include a layer of metal foil for enhanced x-ray        opacity of the sponge.    -   43. A surgical sponge with radio-frequency identification (RFID)        counting and detection comprising:        -   a surgical sponge;        -   a flexible RFID identifier that includes an antenna and an            electrically responsive member which are laminated between a            base film layer and a first protective layer creating a            flexible RFID tag;        -   the flexible RFID tag is positioned between the layers of            the sponge material;        -   wherein one or more of the base film layer and the first            protective film layer is made of colored polymeric film for            enhanced visibility.    -   44. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the antenna is at least one of: an etched        metal foil loop antenna or a wound wire loop antenna.    -   45. The surgical sponge of embodiment 44 or any previous        embodiment, wherein the antenna is a loop antenna that is        substantially square configuration in order to maximize the        antenna size relative to the substantially square surgical        sponges.    -   46. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the electrically responsive member includes        at least one of: programmable integrated circuit (IC) chip, or a        capacitor, or a capacitor and resistor.    -   47. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the tag includes two or more polymeric        protective film layers.    -   48. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the polymeric protective film layer is        colored white.    -   49. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the polymeric protective film layer is        colored a bright color that contrasts with blood and tissue.    -   50. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the polymeric protective film layer is        colored a bright fluorescent colors such as green or yellow.    -   51. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the polymeric protective film layer is        colored such that it fluoresces when illuminated by an        ultraviolet or other specifically selected light source.    -   52. The surgical sponge of embodiment 43 or any previous        embodiment, the polymeric base and protective film layers are        removed from a portion of the central area creating a hole        through the polymeric film for improved flexibility.    -   53. The surgical sponge of embodiment 43 or any previous        embodiment, the polymeric protective film layer is hydrophobic        repelling blood from coating and obscuring the film.    -   54. The surgical sponge of embodiment 43 or any previous        embodiment, wherein the polymeric protective film layer is        hydrophobic relative to the absorbent sponge material repelling        blood from coating and obscuring the film.    -   55. A surgical sponge with a visual identifier comprising:        -   a surgical sponge;        -   one or more layers of flexible, nonabsorbent polymeric film            is interposed between the fabric layers of the sponge and is            attached to the sponge; and        -   includes one or more tabs of the polymeric film that project            beyond the outer edge of the sponge; wherein        -   the layer of polymeric film is colored for enhanced            visibility.    -   56. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is colored white.    -   57. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is colored a bright color        that contrasts with blood and tissue.    -   58. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is colored a bright        fluorescent colors such as green or yellow.    -   59. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is colored such that it        fluoresces when illuminated by an ultraviolet or other        specifically selected light source.    -   60. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is removed from a portion        of the central area creating a hole through the polymeric film        for improved flexibility.    -   61. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film includes a laminated        layer of radio-opaque metal foil across some or all of its        surface.    -   62. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is hydrophobic repelling        blood from coating and obscuring the film.    -   63. The surgical sponge of embodiment 55 or any previous        embodiment, wherein the polymeric film is hydrophobic relative        to the absorbent sponge material repelling blood from coating        and obscuring the film.    -   64. Surgical sponges with radio-frequency identification (RFID)        counting and detection comprising:        -   a plurality of surgical sponges;        -   a plurality of flexible inlay RFID tags that include a loop            antenna and a programmable integrated circuit (IC) chip            which are laminated between a base film layer and a first            protective film layer;        -   the flexible inlay RFID tags are attached to the surgical            sponges;        -   wherein the sponges with attached RFID tags are loosely            attached to a dispensing card that arranges the sponges in a            partially overlapping condition so that the loop antennae            cross each other but do not closely stack on each other.    -   65. The surgical sponges of embodiment 64 or any previous        embodiment, wherein loop antennae are substantially square and        are oriented on the substantially square surgical sponges with        the straight portions of the loop antennae substantially        parallel to the straight edges of the sponges.    -   66. The surgical sponges of embodiment 65 or any previous        embodiment, wherein the loop antennae are substantially circular        and are sized to fit within the substantially square surgical        sponges.    -   67. The surgical sponges of embodiment 64 or any previous        embodiment, wherein the sponges are oriented diagonally on the        card so that the most overlapping point is a corner.    -   68. The surgical sponges of embodiment 64 or any previous        embodiment, wherein the card includes adhesive for securing the        sponges.    -   69. The surgical sponges of embodiment 64 or any previous        embodiment, wherein he card includes slits for securing the        sponges.    -   70. The surgical sponges of embodiment 64 or any previous        embodiment, wherein he slits are horizontal or semicircular and        are sized to allow ⅓ to ⅔ of the area of the sponge to fit        through the slit and thus be positioned on the opposite side of        the card.    -   71. The surgical sponges of embodiment 64 or any previous        embodiment, wherein the card include an area of adhesive on its        back side for removably attaching the dispensing card to the        surgical instrument table.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an identifier according to a non-limitingillustrative embodiment;

FIG. 2 is a top view of an identifier according to another non-limitingillustrative embodiment;

FIG. 3 is a top view of an identifier according to another non-limitingillustrative embodiment;

FIG. 4 is a top perspective view of a tag according to a is anon-limiting illustrative embodiment having the identifier of FIG. 3;

FIG. 5 is a top view of an identifier according to a non-limitingillustrative embodiment;

FIG. 6 is a top view of a tag according to a is a non-limitingillustrative embodiment having the identifier of FIG. 5;

FIG. 7 is a top view of an identifier according to a non-limitingillustrative embodiment;

FIG. 8 is a top view of a tag according to a is a non-limitingillustrative embodiment having the identifier of FIG. 7;

FIG. 9 is a top view of an identifier according to a non-limitingillustrative embodiment;

FIG. 10 is a top view of a tag according to a is a non-limitingillustrative embodiment having the identifier of FIG. 8;

FIG. 11 is a top view of a surgical sponge according to a non-limitingillustrative embodiment having a tag according to any of the illustratedembodiments sewn to the sponge;

FIG. 12 is a top view of a surgical sponge according to anothernon-limiting illustrative embodiment having a tag according to any ofthe illustrated embodiments heat bonded to the sponge;

FIG. 13 is a schematic illustrating a method of manufacturing surgicalsponges that include tags according to an exemplary embodiment;

FIG. 14 is a schematic illustrating a method of manufacturing surgicalsponges that include tags according to another exemplary embodiment;

FIG. 15 is a schematic illustrating a packaged bundle of spongesaccording to a non-limiting exemplary embodiment; and

FIG. 16 is a schematic illustrating a packaged bundle of spongesaccording to a non-limiting exemplary embodiment.

DETAILED DESCRIPTION

Some embodiments of this disclosure provide a surgical sponge having anabsorbent body and one or more identifiers attached to or embeddedwithin the sponge. Certain embodiments of this disclosure also provide asurgical sponge counting and detection system for counting surgicalsponges, and a method for counting and detection of surgical sponges.The present disclosure may reduce the likelihood that a sponge willremain in a patient after surgery and may reduce the time involved inaccounting for sponges during surgery.

FIGS. 1, 2 and 3 illustrate identifiers for surgical sponges accordingto an embodiment of the present disclosure. In the illustratedembodiments, the identifiers may be Radio Frequency (RF) or RadioFrequency Identification (RFID) identifiers may be made in a relativelyflat configuration. While FIG. 1 illustrates the identifier in agenerally square shape, FIG. 2 illustrates the identifier in a generallycircular shape, and FIG. 3 illustrates the identifiers to be of agenerally rectangular shape. However, identifiers can be virtually anyother shape. In some embodiments, the identifier 10 may consist of anantenna 12 which may be made of etched metal foil traces or printedtraces of conductive ink or multiple loops of wire. Other antennaconstructions are anticipated.

With reference to FIGS. 1, 2 and 3, in non-limiting illustrativeembodiments, the antenna 12 is attached to a base layer 14. In the caseof an etched metal foil antenna, the metal foil may be applied to thebase layer 14 before the etching process occurs. In the case of aprinted conductive ink antenna, the conductive ink may be printed on tothe base layer 14. The base layer 14 provides structural strength forthe very fragile metal or ink traces, especially preventing stretchingthat would fracture the traces. In the case of antennae made of multipleloops of wire, the wire loops may be attached to the base layer 14during or after the winding process.

In some advantageous aspects of the disclosure, the base layer 14 can bemade of a relatively stretch-resistant polymeric film, to prevent theidentifier 10 from stretching and fracturing the fragile antenna traces12. Suitable stretch-resistant polymeric films include but are notlimited to: polyethylene terephthalate (PET), polypropylene (PP),polyester (PE) and nylon. In some embodiments, paper may be substitutedfor the stretch-resistant polymeric base film layer 14.

Referring again to the non-limiting illustrative embodiments of FIGS.1-3, an electrically responsive member 16 is electrically connected tothe antenna 12. The electrically responsive member 16 may include anintegrated circuit (IC) chip.

In some embodiments, the electrically responsive member 16 may include acapacitor with our without a resistor or other electrical components. Inthis case, the resulting identifier 10 is a Radio Frequency (RF) or LowFrequency (LF) identifier.

In some embodiments, when the identifier 10 is made with an etched foilantenna or a printed conductive ink antenna 12, the identifier 10 cancalled an “inlay.” In some such embodiments, the identifiers 10 can bemade by an economical, fully automated process with excellent qualitycontrols.

As shown in the illustrative embodiment of FIG. 4, inlay identifier 10may be laminated between one or more protective film layers 18, 20.First protective film layer 18 may be laminated over the exposed etchedmetal foil or printed conductive ink traces 12 and the electricallyresponsive member 16. First protective film layer 18 protects certaincomponents of the identifier 10 from mechanical damage as well as damagefrom liquids such as blood. First protective film layer 18 also reducesthe chance of liquids (e.g., blood or medical fluids) from electricallyshorting out the RFID or RF circuit. The laminated identifier can alsobe referred to as a tag 24.

With continued reference to the non-limiting exemplary embodiment ofFIG. 4, a second protective film layer 20 may be laminated to theidentifier. The second protective film layer 20 can be opposite thefirst protective film layer 18. This configuration sandwiches theidentifier 10 in between two protective film layers 18, 20, for addedsecurity and durability. Further, when laminated on both sides, theidentifier 10 can sometimes be referred to as a tag 24.

In certain aspects of the disclosure, the protective film layers 18, 20may be made of polymeric film that is flexible and may also berelatively resistant to tearing. Suitable tear-resistant polymeric filmsinclude but are not limited to: urethane, nylon and polyvinylchloride(PVC).

The thickness of the one or more protective film layers 18, 20 may begreater than 0.003 in. (3 mil.) in some exemplary embodiments. This mayreduce kinking of the inlay antenna 12 (and associated fracture) duringsevere bending because the radius of the bend may be greater than the0.003 in. thickness of the protective film.

In some embodiments, the base layer 14 is bonded to one or moreprotective film layers 18, 20. The layers may be bonded together usingadhesive 22. Suitable adhesives include but are not limited to: pressuresensitive adhesives (PSA), hot melt adhesives and various liquid appliedadhesives that require curing. Curing may include the application of UVlight. In the case of other adhesives such as epoxy, curing may includethe addition of a catalyst.

While some desirable properties of the adhesive 22 are mentioned above,it may be additionally desirable for the adhesive 22 to be flexible,water resistant, heat tolerant (up to steam autoclave temperatures, 250°F.), relatively fast curing and durable.

In some embodiments, the base layer 14 and/or the one or more protectivefilm layers 18, 20 may be plasma etched prior to the application ofadhesive 22 to improve the adherence of the adhesive 22 to the filmlayers 14, 18, 20. Alternatively, the base layer 14 and/or the one ormore protective film layers 18, 20 may be bonded together using heatbonding, ultrasound (US) bonding, radio-frequency (RF) bonding or otherbonding methods.

As shown in FIGS. 1-3 and 5 in some embodiments when the antenna 12 issquare, circular, or rectangular, a space 26 is present within the innerperimeter of the antenna that is void of metal foil traces.

As shown by the embodiments of FIGS. 1-3,5 and 6, the base layer 14 andthe one or more protective film layers 18, 20 within the area 26 definedby the inner perimeter of the antenna trace 28 may be removed, creatinga hole 30 through the central area of the tag 24. Removing the layers offilm substantially in the middle of the tag 24 may improve theflexibility of the tag. The hole 30 in the tag 24 can allows astretching or planar deformation of the tag 24 (e.g., along arrows 3Aindicated in FIG. 4) that cannot generally occur with complete sheets ofpolymeric film. In addition, the tag 24 may be flexible, such that edges24A, 24B may be brought toward each other, permitting the tag 24 to bebent. The hole 30 in the tag 24 allows the tag to feel much like thelayers of the fabric sponge that it will be embedded in, rather thanfeel like a sheet of plastic in the sponge. The flexible and stretchabletag 24 can thus be generally inconspicuous to touch when attached to thesurgical sponge.

Referring back to the illustrative embodiments of FIGS. 1-3, the hole 30in the identifier 10 or tag is substantially square, circular, orrectangular, though other shapes including oval and irregular shapes arecontemplated within the scope of the present disclosure. The shape ofthe hole 30 may match the shape of the tag 10 and may also be square,circular or rectangular. The hole 30 may advantageously include roundedcorners to reduce the chances of tearing.

In some embodiments, if the antenna shape is more complex (e.g., afour-leaf clover), there may be cuts made through the base andprotective film layers between the antenna traces, without removing filmmaterial to create a hole. The cuts, even in the absence of holes,improve the flexibility and stretch-ability of the tag. Alternately, thecuts may be made inward from the outer perimeter of the tag.

In some such embodiments, cuts may be made through the base andprotective film layers in any areas of the tag not occupied by eitherthe antenna or electrically responsive member. The cuts improve theflexibility and stretch-ability of the tag, making it feel more like asurgical sponge.

As shown by the non-limiting illustrative embodiments of FIGS. 5 and 6,some of the material of the base 14 and protective film layers 18, 20may be left within the perimeter 28 of the hole 30 in the tag 24. Thefilm layers of material may be in the shape of one or more tabs 32extending radially inward from the inner perimeter 28 of the hole 30.The tabs 32 can be any shape or size, including less than 0.5 inchessquare. As shown in FIG. 10, if flexibility is desired, tabs 32 may beattached to the tag 24 by way of a narrowed isthmus 36 of laminated base14 and protective film layers 18, 20.

As shown by the non-limiting exemplary embodiment of FIGS. 7 and 8, someof the material of the base 14 and protective film layers 18, 20 may beleft extending outward from the outer perimeter 34 of the tag 24. Thematerial may be in the shape of one or more tabs 32 extending radiallyoutward. The tabs 32 can be of any shape or size, including less than0.75 inches square. If flexibility is desired, tabs 32 may be attachedto the tag 24 by way of a narrowed isthmus 36 of laminated base 14 andprotective film layers 18, 20.

Referring now to the non-limiting exemplary embodiment of FIG. 9, thetab 32 may be in the form of one or more elongate protrusions from theouter perimeter 34 of the tag 24. In such embodiments, it may beadvantageous if the elongate protrusion 32 extends beyond the border ofthe sponge (not shown) that the tag 24 may be embedded within. In thisexposed position, the tab 32 may provide added visibility of a spongehaving blood to the surgeon or a handle to grasp by the surgeon ornurse. This may be useful when removing a sponge during laparoscopicsurgery. The exposed tab 32 may provide enhanced visibility,differentiation and pattern recognition to the nurse or surgicaltechnician for identifying individual sponges. In this exposed position,the tab 32 may provide an object for accurate indexing during both theplacement and securement of the tag to the sponge during an automatedmanufacturing process and an object for machine vision opticalinspections and counting during manufacturing, or other uses.

FIG. 10 illustrates a tag according to another non-limiting exemplaryembodiment. As seen in FIG. 10, the tab 32 may be a substantiallysemicircular or “D” shaped protrusion from the outer perimeter 34 of thetag 24. An optional hole 38 may be provided in the central portion ofthe tab 32. Tab 32 can protrude from the outer perimeter 34 of the tag24. The tab 32 can be of any shape. In some embodiments, it may beadvantageous if the tab 32 extends beyond the border of the sponge (notshown) that the tag 24 may be embedded within. In this exposed position,the tab 32 may provide added visibility of a sponge having blood to thesurgeon or a handle to grasp by the surgeon or nurse. This may be usefulwhen removing a sponge during laparoscopic surgery. The exposed tab 32may provide enhanced visibility, differentiation and pattern recognitionto the nurse or surgical technician for identifying individual sponges.In this exposed position, the tab 32 may provide an object for accurateindexing during both the placement and securement of the tag to thesponge during the manufacturing process and an object for machine visionoptical inspections and counting during manufacturing, or other uses.

Referring back to FIGS. 6 and 8, the tabs 32 may, optionally, extendinward into the hole 30 or outward from the outer perimeter 34 of thetag 24 are used for anchoring the tag 24 to the sponge (not shown)without damaging the fragile antenna. As shown in FIGS. 5 and 7, thetabs 32 can be spatially separated from the antenna trace 12 andelectrically responsive member 16 of the inlay identifier 10. Therefore,the attachment of the tag 24 to the sponge (not shown) at the tab 32 maybe less likely to damage the electronics and antenna of the identifier10 during the attachment process.

FIG. 11 illustrates a sponge provided with a tag according to anexemplary embodiment. In the illustrated embodiment of FIG. 11, the tag24 can be sewn to the sponge 40, though, other methods of securelyattaching the tag 24 to the sponge 40 is contemplated within the scopeof the present disclosure. The tag 24 can be attached to the sponge 40by sewing through both the sponge material 40 and the base layer andprotective film layer of the tag 24. Sewing through the one or more tabs32 (e.g., along marks 42) reduces the chance of cutting a foil trace ofthe antenna, a printed conductive ink trace or a wire of the antennawith the sewing needle. The tab 32 also allows the backstitch anchoring44 of the sewing seam 42 to occur off the side edge of the tab 32, inthe sponge material 40 only. The sewing seam 42 may cross the tab butmay be backstitch anchored 44 adjacent each side of the tab 32 in thesponge material 40. The multiple sewing pierces created by a backstitchanchor seam 44, could substantially weaken the film laminate and allowtearing of the film to start at that location if the backstitching 44were to land on the tab 32.

As shown in FIG. 12, in some embodiments, the one or more tabs 32 may bea safe area for heat bonding 46 the tag 24 to the sponge 40. Heatbonding may be accomplished by applying a hot object to one or morelayers of the sponge fabric 40 while pushing the threads of the fabricdown onto the one or more protective film layers of the tab 32. Theheated object warms and partially melts the polymeric film, embeddingthe threads of the sponge 40 into the melted film 46. When the polymericfilm cools, the fabric of the sponge 40 is securely adhered to theplastic film of the tag 24. The tabs 32 create an area for heating thatis geographically separated from the from the antenna trace 12 andelectrically responsive member 16 of the identifier, thus reducing thepotential of damaging the identifier during the process of heat bondingthe sponge 40 to the tag 24.

Heat bonding 46 may be advantageous if an automated manufacturingprocess is used for manufacturing the sponges. Accordingly, the presentdisclosure provides a method of manufacturing surgical sponges thatinclude tags 24 or markers (markers are tags without an inlay RFIDidentifier) that have an outer protective layer 18, 20 of polymericfilm. FIGS. 13 and 14 illustrate some such exemplary embodiments. In anexample, a method of manufacturing surgical sponges 40 includes foldinga sheet of gauze fabric 56 one or more times and interposing the tag 24or marker between the folded layers of gauze fabric 56. As shown in FIG.14, one or more heated metal members 54 maybe pushed against the one ormore layers of gauze fabric 56, pushing the gauze fabric 56 firmlyagainst the polymeric film 18, 20. The one or more heated metal members54 are shaped, positioned and indexed to apply heat to areas of the tag24 or marker that will not be damaged by the heat 46.

The heated metal member 54 is heated to a temperature that is greaterthan the melting point of the selected polymeric film 18, 20. The heatfrom the heated metal member 54 melts the polymeric film 18, 20 and thepressure against the gauze fabric 56 from the heated metal member 54pushes one or more layers of the fabric 56 into the melted polymericfilm 18, 20. The heated metal member 54 is then retracted from thefabric 56, and as the melted polymeric film layer 18, 20 cools, it bondsto the embedded gauze fabric 56. Applying the heat through the gauzefabric 56 may reduce the chances of the melted polymeric film 18, 20from adhering to the heated metal member 54. If speed is desirable, theheated metal member 54 may be heated to a temperature significantlygreater than the melting temperature of the polymeric film 18, 20. Thefolding of the gauze fabric 56, the indexing of the tag 24 or markerwithin the layers of gauze fabric 56 and the application of heat fromthe heated metal member 54 may be automated for economicalmanufacturing.

FIG. 14 illustrates a method of manufacturing sponges according toanother exemplary embodiment. In the embodiment of FIG. 14, heat may besimultaneously applied to both sides of the sponge thus heat bonding thegauze fabric 56 to both sides of the tag 24. Applying the heatsimultaneously to both sides of the tag 24, reduces the time required tomelt the polymeric film 18, 20 and create a bond with the gauze fabric56. Alternatively, it is anticipated that the heat may be applied toonly one side of the tag 24.

Referring back to FIGS. 11 and 12, in certain exemplary embodiments, anattached, flexible RFID or RF inlay tag 24 may also be attached to thesponge 40 according to the above-disclosed method of manufacturingsurgical sponges. The attachment location between the sponge 40 and thetag 24 may be at the one or more tabs 32. Because the tabs 32 arephysically separated from the functional parts of the identifier 10,less precision is sufficient when applying pressure and heat or piercingwith sewing needles to avoid damaging the identifier 10, and therebypermitting automation of the manufacturing process.

As mentioned above, the one or more tabs become a safe and flexible areafor adhesively bonding the tag to the sponge. Fast curing adhesives suchas epoxy are frequently stiff. Applying a stiff adhesive to the tag 24may result in a stiff tag 24. Applying a stiff adhesive to a tab 32 maymaintain the general flexibility of the tag 24.

As shown by the non-limiting illustrative embodiment of FIG. 9, themetal foil inlay identifier 12 or the metal wire of a loop antenna 12creates a densely radio-opaque area that is easy to visualize by x-ray.Metal foil or wire is much more radio-opaque than barium sulfate. Insome embodiments, extra conductive ink may be applied, especiallyconductive inks that contain metals, to increase the radio-opacity ofthe tag.

Excess metal foil 48 may be purposefully left on the base layer 14during the etching process, substantially increasing the square area ofthe metal foil x-ray opacity at no extra cost. The extra metal foil 48may or may not be electrically connected to the antenna 12. The extrafoil adds additional radio-opacity to the tag for better x-rayvisualization. In some such aspects, the extra metal foil 48 may belocated substantially within the outer perimeter 34 of the tag 24. Inaddition, the extra metal foil 48 may be located substantially outsidethe outer perimeter 34 of the tag 24.

With continued reference to FIG. 9, the extra metal foil 48 may belocated in the one or more tabs 32. The tabs 32 can fold and bendrelative to the main body of the tag 24. Including a layer of metal foil48 in the tabs 32 therefore increases the probability of some of thefoil 48 being oriented substantially perpendicular to the x-ray beamwhen the sponge (not shown) is crumpled into a three dimensionalwad-shape and left in the body.

The protective layer of polymeric film 18, 20 may optionally be colored.For instance, the protective layer of polymeric film 18, 20 may not beclear. Additionally, the protective layer 18, 20 may be coated withpigment to make the tag 24 more visible to the surgeon. Bright colorsmay contrast with blood and tissue and therefore improve visibility.Suitable colors include but are not limited to: green, yellow, purple,blue and white. In an example, the protective layer 18, 20 can be coatedwith simple bright pigments or “neon” or “fluorescent” pigments, forinstance, those made by the DayGlo Color Corp. (Cleveland, Ohio).

Continuing with the advantageous exemplary aspects described above, theprotective layers 18, 20, when coated with pigments may optionally“fluoresce” when illuminated by UV light or colored lights, causing thefluorescent pigments in the tag 24 to become more visible. For instance,particles or spheres of material such as glass or plastic that reflectlight may be embedded in the polymeric film. Alternatively, a layer ofreflective film may be used for one or more of the protective filmlayers 18, 20. In further aspects of the disclosure, one or more layersof reflective film may be laminated to the one or more protective filmlayers 18, 20.

In certain exemplary embodiments, the one or more protective film layers18, 20 maybe made of a substantially hydrophobic polymeric material toprevent blood from coating the brightly colored film and obscuring thetag 24 or marker from the surgeons view. Alternatively, a hydrophobicmaterial may be coated on to the protective layers 18, 20. For instance,polymeric films that are hydrophobic relative to the absorbent,hydrophilic properties of a fabric sponge are contemplated for use.Additionally, the surface of the protective film layers 18, 20 may becoated with a hydrophobic material that further enhances the hydrophobicnature of the film.

Enhanced surgical sponge visualization and/or enhanced surgical spongex-ray opacity may be desirable without RFID. Accordingly, in certaincases, inexpensive and easily identifiable polymeric film “markers” maybe made similarly to the RFID tags 24 previously discussed except thatthe inlay identifier 10 is omitted. For instance, the markers may bemade of one or more layers of colored, hydrophobic polymeric film 18, 20as previously discussed for RFID tags. The markers may include a metalfoil layer for x-ray opacity.

The marker may be any size or shape that can fit within the area of asponge. In some cases, the marker may include tabs 32 as previouslydisclosed on tag 24. The polymeric film marker may then be positionedbetween the layers of the surgical sponge. As shown by the non-limitingexample of FIG. 10, and as described previously, tabs 32 may extendradially outward from the outer perimeter of the marker and the radialextension may be positioned to extend beyond the perimeter of the sponge(not shown). In this location, the colored marker is more visible to thesurgeon when the sponge is in the patient and the sponge is saturated inblood.

Without RFID tags, these sponges with markers will have to behand-counted by the nurse. Colored markers extending beyond the edge ofthe surgical sponges are much easier to identify individually and countthan is a stack of homogeneous white sponges. Exposed tabs 32 may reducethe need to unfold each blood-laden sponge to assure that two spongesare not stuck together during manual counting. This makes manualcounting much easier and faster.

The colored marker may optionally be attached to the fabric of thesponge by heat bonding or sewing as previously described for a tag 24.As illustrated by the exemplary embodiment of FIGS. 13 and 14, heatbonding or sewing the marker to the sponge may allow the surgical spongemanufacturing process to be automated, and thereby more economic.

While the description generally focuses on attachment of brightlycolored flexible markers or RFID tags 24 to surgical sponges, a skilledartisan would appreciate that such markers or RFID tags 24 described inthe present disclosure may also be attached to other surgical articlesfor enhanced visual identification or RFID identification. The brightcolors of a tag 24 or marker make the surgical item easier to see bothinside and outside the patients' body. Other surgical items may includebut are not limited to: surgical instruments, pledgets, cannulas,tubing, drains, stints, clamps, foam, retractors and sutures.

Traditionally a number of surgical sponges (e.g., a set of five or tensponges) may be packaged together (e.g., stacked on top of each other).If smaller sponges that contain RFID tags are packaged side-by-side in abundle, the RFID antennae may proximate each other and causeinterference or “coupling” during the sponge entry process.

FIGS. 15 and 16 illustrate a packaged bundle of sponges according to anon-limiting exemplary embodiment. While FIGS. 15 and 16 illustrate apackage of sponges, other surgical articles including but are notlimited to: surgical instruments, pledgets, cannulas, tubing, drains,stints, clamps, foam, retractors and sutures may also be used instead ofsponges. As seen by the embodiments of FIGS. 15 and 16, the sponges 40may be removably attached to a sponge dispensing card 50. The spongedispensing card 50 can spread the sponges 40 out so that their antennae12 only partially overlap, decreasing the chances of “coupling.”

The sponge dispensing card 50 may be made of cardboard or plastic insome cases. The sponge dispensing card 50 may be of any shape includingbut not limited to round, square and rectangular.

In an example, the sponges 40 may be attached to the sponge dispensingcard 50 by one or more slits 52 in the card 50 through which a portionof the sponge 40 can pass. The slits 52 may spread the sponges 40 outover the face of the card 50 and retain the sponge 40 and yet allow easeof removal of the sponge 40 from the sponge dispensing card 50. Theslits 52 through the card 50 may be generally straight, generallysemi-circular, angled or any other shape and length. A semi-circularslit 52 may be advantageous during the process (e.g., an automatedprocess) of loading the sponge 40 into the slit 52. A semi-circular slit52 allows a greater opening of the space for insertion of the sponge 40.The slits 52 can additionally reduce the possibility of adhesive fromsticking to the material of the sponge 40 upon removal from the card 50.The slits 52 can be sized to allow between about ⅓ and about ⅔ of thearea of each sponge to fit through the corresponding slit 52. Wheninserted as such at least opposite edges 40A and 40B of each sponge canbe positioned on the opposite side of the card.

As illustrated in FIGS. 15 and 16, according to an embodiment, sponges40 can be attached the sponge dispensing card 50 by a releasableadhesive. In some embodiments, the attachment of sponges 40 to thesponge dispensing card 50 may be made by folding the card 50 to create apocket that can accommodate a portion of each sponge. Other attachmentmethods are anticipated. When assembled according to some exemplaryembodiments, the sponges 40 may be spread out over the surface of thesponge dispensing card 50 so that their antennae may overlap orcrossover but do not stack.

Spreading the sponges 40 out over the surface of the sponge dispensingcard 50 also decreases the chances of erroneously packaging the wrongnumber of sponges 40 in the pack at the factory. If each location on thesponge dispensing card 50 is occupied by a single sponge 40, the correctnumber of sponges 40 can be reliably identified with a cursory visual ormachine inspection during the manufacturing process. Added visibilityfor a cursory inspection can be achieved by adding a colored spot 58 tothe card 50 in a location that will be covered and obscured by properlyinserted sponges 40. Any missing sponge 40 will expose the easilyidentifiable bright colored spot 58. To prevent two sponges 40 frombeing inadvertently inserted into a single slit 52, the length of theslit 52 may be limited to a shorter length that does not accommodate twosponges. In the alternative, if the sponges are in a stack, they may behand separated and counted one at a time to determine if the rightnumber is in the package.

In some embodiments, spreading the sponges 40 out over the surface ofthe sponge dispensing card 50 may allow the nurse or surgical technicianto quickly and accurately visually count the sponges 40 during the entryprocess. If each location on the sponge dispensing card 50 is occupiedby a single sponge 40, the correct number of sponges 40 can be reliablyidentified with a cursory visual inspection rather than the manualcounting of the sponges 40. This may be advantageous in the case ofsponges 40 that contain markers that do not have RFID or RF capabilityand therefore may have to be counted manually.

In some embodiments, the sponge dispensing card 50 may include apressure sensitive adhesive area designed to stick the card to thesurgical instrument table. This pressure sensitive adhesive may securethe card 50 to the table allowing easier dispensing of the sponges 40from the card 50.

Various examples have been described. These and other examples arewithin the scope of the following claims.

What is claimed is:
 1. A surgical sponge, comprising: a sponge body; and a radiofrequency (RF) tag positioned interior to the sponge body, the tag comprising: a radiofrequency (RF) identifier comprising an antenna and an electrically responsive member, a base layer having at least one tab projecting from an outer perimeter of the RF identifier, the base layer comprising a first polymeric film material, a first protective layer having at least one tab projecting from the outer perimeter of the RF identifier and generally aligned with the at least one tab of the base layer, the first protective layer comprising a second polymeric material, wherein the RF identifier is laminated between the base layer and the first protective layer.
 2. The surgical sponge of claim 1, wherein the antenna is at least one of an etched metal foil antenna and a wound wire antenna.
 3. The surgical sponge of claim 1, wherein the electrically responsive member includes at least one of programmable integrated circuit (IC) chip, a capacitor, and a resistor.
 4. The surgical sponge of claim 1, wherein the tag includes a second protective layer positioned opposite to the first protective layer, the second protective layer comprising a polymeric film material, the second protective layer and the first protective layer substantially enclosing the base layer and the identifier.
 5. The surgical sponge of claim 5, wherein the polymeric film material is a flexible tear-resistant film.
 6. The surgical sponge of claim 1, wherein the tag is attached to the sponge body at a location corresponding to the at least one tab of each of the first protective layer and the base layer.
 7. The surgical sponge of claim 6, wherein the tag is attached to the sponge body by at least one of sewing and heat bonding.
 8. The surgical sponge of claim 7, wherein fibers of the surgical sponge are pressed into the polymeric film material that has been heated and partially melted, creating a heat bond between the fibers and the polymeric film material.
 9. The surgical sponge of claim 1, wherein the at least one tab of each of the first protective layer and the base layer project radially outward beyond an edge of the sponge body when the tag is attached to the sponge body.
 10. The surgical sponge of claim 1, wherein one or more of the base layer and the one or more polymeric protective film layers is made of colored polymeric film for so as to contrast with blood and tissue.
 11. The surgical sponge of claim 1 wherein the one or more of the polymeric protective film layers is configured to fluoresce when illuminated by a light source at a predetermined wavelength.
 12. The surgical sponge of claim 1, wherein the one or more polymeric protective film layers are hydrophobic relative to the surgical sponge, the one or more polymeric protective film layers being configured for repelling blood.
 13. A surgical sponge, comprising: a sponge body; and a radiofrequency (RF) tag attached within an interior portion of the sponge body, the tag comprising: a base layer, a radiofrequency (RF) identifier comprising a metal foil antenna etched on to the base layer and an electrically responsive member, additional metal foil remaining on the base layer when the metal foil antenna is etched on to the base layer, the additional metal foil configured to enhance x-ray opacity of the surgical sponge, a first polymeric film protective layer with the metal foil antenna and the electrically responsive member being laminated between the first protective film layer and the base layer, wherein each of the base layer and the protective film layer has one or more tabs that project outward from an outer perimeter of the RF identifier.
 14. The surgical sponge of claim 13, wherein the electrically responsive member includes at least one of programmable integrated circuit (IC) chip, a capacitor, and a resistor.
 15. The surgical sponge of claim 13, wherein the tag includes a second protective layer positioned opposite to the first protective layer, the second protective layer comprising a polymeric film material, the second protective layer and the first protective layer substantially enclosing the base layer, the metal foil antenna and the electrically responsive member.
 16. The surgical sponge of claims 13, wherein the tag is attached to the sponge body at a location corresponding to the at least one tab of each of the first protective layer and the base layer by at least one of sewing and heat bonding.
 17. The surgical sponge of claim 14, wherein fibers of the surgical sponge are pressed into the polymeric film material that has been heated and partially melted, creating a heat bond between the fibers and the polymeric film material.
 18. The surgical sponge of claim 13, wherein one or more of the base layer and the one or more polymeric protective film layers is made of colored polymeric film for so as to contrast with blood and tissue.
 19. The surgical sponge of claim 13 wherein the one or more of the polymeric protective film layers is configured to fluoresce when illuminated by a light source at a predetermined wavelength.
 20. The surgical sponge of claim 13, wherein the one or more polymeric protective film layers are hydrophobic relative to the surgical sponge, the one or more polymeric protective film layers being configured for repelling blood.
 21. A surgical sponge, comprising: a sponge body; and a radiofrequency (RF) tag positioned interior to the sponge body, the tag comprising: a base layer comprising a first polymeric film material, a radiofrequency (RF) identifier comprising at least an antenna and an electrically responsive member attached to the base layer, the base layer having at least one tab projecting from an outer perimeter of the RF identifier, a first protective layer having at least one tab projecting from the outer perimeter of the RF identifier and generally aligned with the at least one tab of the base layer, the first protective layer comprising a second polymeric material, and the RF identifier is laminated between the base layer and the first protective layer, wherein one or more of the base layer and the one or more polymeric protective film layers is made of colored polymeric film so that it visually contrasts with blood and tissue.
 22. The surgical sponge of claim 21, wherein the antenna is at least one of an etched metal foil antenna and a wound wire antenna.
 23. The surgical sponge of claim 21, wherein the electrically responsive member includes at least one of programmable integrated circuit (IC) chip, a capacitor, and a resistor.
 24. The surgical sponge of claim 21, wherein the tag includes a second protective layer positioned opposite to the first protective layer, the second protective layer comprising a polymeric film material, the second protective layer and the first protective layer substantially enclosing the base layer and the identifier.
 25. The surgical sponge of claim 21, wherein the tag is attached to the sponge body at a location corresponding to the at least one tab of each of the first protective layer and the base layer.
 26. The surgical sponge of claim 25, wherein the tag is attached to the sponge body by at least one of sewing and heat bonding.
 27. The surgical sponge of claim 26, wherein fibers of the surgical sponge are pressed into the polymeric film material that has been heated and partially melted, creating a heat bond between the fibers and the polymeric film material.
 28. The surgical sponge of claim 21, wherein the at least one tab of each of the first protective layer and the base layer project radially outward beyond an edge of the sponge body when the tag is attached to the sponge body.
 29. The surgical sponge of claim 21 wherein the one or more of the polymeric protective film layers is configured to fluoresce when illuminated by a light source at a predetermined wavelength.
 30. The surgical sponge of claim 21, wherein the one or more polymeric protective film layers are hydrophobic relative to the surgical sponge, the one or more polymeric protective film layers being configured for repelling blood. 